FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis in Children Age 2+
FDA approved roflumilast cream 0.3% (Zoryve) for plaque psoriasis in children age 2+, the first once-daily steroid-free topical for that group. A meta-analysis found it improved IGA scores and was well tolerated.
The FDA approved a supplemental indication for roflumilast cream 0.3% (ZORYVE) down to age 2 on June 29, making it the first once-daily, steroid-free topical approved for plaque psoriasis in that age group.
The approval rests on a 4-week Maximal Usage Systemic Exposure study (ARQ-151-216) in children ages 2 to 5 with plaque psoriasis covering at least 2% body surface area, supplemented by 24 weeks of open-label safety data from extension study ARQ-151-306. Neither was a placebo-controlled efficacy trial in the traditional sense; Arcutis instead anchored the efficacy argument to the DERMIS-1 and DERMIS-2 Phase 3 trials, which evaluated the cream in patients aged 2 and older across 8-week, randomized, double-blind, vehicle-controlled designs, using IGA success (clear or almost clear, with at least a 2-grade improvement from baseline) as the primary endpoint. The FDA accepted that the safety and efficacy profiles observed in the toddler-age cohorts were consistent with those established in adolescents and adults.
What makes this approval clinically meaningful is not just the age extension but the absence of site-specific or duration-based restrictions. Topical steroids remain guideline-unsupported for long-term use on the face, skin folds, and genitals, precisely the areas where psoriasis in young children tends to concentrate. Roflumilast cream 0.3% carries no such limitations, which closes a real prescribing gap rather than an incremental one. The drug is now the only topical PDE4 inhibitor indicated for plaque psoriasis in children under 6, and its label explicitly includes intertriginous areas.
Arcutis has also layered in a prior 0.05% roflumilast cream approval for atopic dermatitis in the same 2-to-5 age band, meaning the company now holds two distinct pediatric roflumilast franchises in overlapping patient populations.
In a systematic review and meta-analysis of randomized trials identified across four databases through March 2024, roflumilast was associated with higher rates of improvement on Investigator’s Global Assessment outcomes compared with placebo. More patients receiving roflumilast achieved an Investigator’s Global Assessment score of 0 or 1 and a 2 point improvement at both Week 4 and Week 8. The pooled analysis also favored roflumilast on measures related to the Psoriasis Area and Severity Index, with most comparisons indicating improved response versus placebo at the same timepoints. Across included studies, roflumilast was described as well tolerated overall. The authors conclude that these findings support roflumilast as an effective and generally tolerable option for psoriasis management in the analyzed trials. However, they also emphasize the need for additional robust clinical trials to confirm the magnitude of benefit, clarify durability, and further characterize safety across broader patient populations.